Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence

This study is currently recruiting participants.

Verified January 2012 by Fisher and Paykel Healthcare

Sponsor:

Collaborator:

Helios Klinik Ambrock

Information provided by (Responsible Party):

Fisher and Paykel Healthcare

ClinicalTrials.gov Identifier:

NCT01517750

First received: January 18, 2012

Last updated: January 22, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 18, 2012

Last Updated Date

January 22, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Therapy adherence with treatment per night averaged over total time period measured via internal software on the device and reported on using InfoSmart™ software with and without heated humidification. [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01517750 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Prediction of the need of humidification use before therapy. [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]

Prediction of the need of humidification use before therapy. Which patients are likely to profit from heated humidification with tube heating.

Acceptance rate, drop-out rate, leak, ESS score, Rhino FB score, self-reported nasal symptoms, and functional outcomes of sleep questionnaire score.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence

Official Title ^ICMJE

Not Provided

Brief Summary

Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal. One of the only technological advancements shown to increase adherence is heated humidification, now considered part of conventional CPAP therapy in some countries. ThermoSmart™ is a unique technology developed by Fisher & Paykel Healthcare which utilises a heated breathing tube to deliver optimal humidity in all environments. ThermoSmart has been shown to be superior to conventional humidification in reducing side effects, condensation and titrated pressure as well as increasing total sleep time. However, improved humidity delivery has not lead to significantly increased adherence in unselected obstructive sleep apnea (OSA) patients.

A total of 80 patients diagnosed with OSA but naive to CPAP use will be randomized into a single blind, randomized, parallel-arm trial to determine whether the the use of heated humidification will impact therapy adherence.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Sleep Apnea, Obstructive

Intervention ^ICMJE

Device: ICON Auto CPAP™ with Thermosmart heated tube
ICON Auto CPAP™ with heated humidification and the use of a heated tube
Device: ICON Auto CPAP™ without Thermosmart heated tube
ICON Auto CPAP™ without heated humidification or the use of e aheated tube.

Study Arm (s)

Experimental: APAP with humidification
ICON Auto CPAP™ with Thermosmart heated tube

Intervention: Device: ICON Auto CPAP™ with Thermosmart heated tube
Active Comparator: APAP without humidification
ICON Auto CPAP™ without Thermosmart heated tube

Intervention: Device: ICON Auto CPAP™ without Thermosmart heated tube

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosed with OSA
Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years
Prescribed a nasal mask (as patients will be prescribed their mask following recruitment into the study, any participants who are prescribed a full face mask will be withdrawn)

Exclusion Criteria:

Severe heart disease
Co-existing lung disease
Co-existing sleep disorders
Pregnant

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hanie Shahpari, MSc

+6495740123 ext 7909

hanie.shahpari@fphcare.co.nz

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01517750

Other Study ID Numbers ^ICMJE

FPH-OSA-TS-2012

Has Data Monitoring Committee

Responsible Party

Fisher and Paykel Healthcare

Study Sponsor ^ICMJE

Fisher and Paykel Healthcare

Collaborators ^ICMJE

Helios Klinik Ambrock

Investigators ^ICMJE

Principal Investigator:

Georg Nilius, Dr.

Helios Klinik Ambrock

Information Provided By

Fisher and Paykel Healthcare

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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